Bayer Corporation and Anr v. Union of India & Ors
Appeal of dismissal of drug company’s petition seeking to prevent Drug Controller General of India (DCGI) from granting another drug company marketing approval of a generic version of its patented drug. Protection of private patent rights at cost of depriving access to and affordability of life-saving treatments, contrary to public health care interests.
In March 2008, Bayer HealthCare LLC, a wholly owned subsidiary of Bayer Corporation, was granted a subject patent by India’s Patent Office, pursuant to the Drugs and Cosmetics Act 1940 (DCA) and Drugs and Cosmetics Rules 1945 (DCR), for “sorafenib tosylate” (ST), commonly prescribed for treatment of advanced renal cancer. Bayer HealthCare LLC subsequently assigned its titles to the patented drug in India to Bayer Corporation (“Bayer”).
In July 2008, Bayer learned that another drug company, Cipla, applied to the Drug Controller General of India (DCGI) for marketing approval of a generic version of ST. Bayer requested that the DCGI not grant such an approval, stating that it alone had the marketing rights to sell the drug in India. Thereafter, Bayer filed a petition in Delhi High Court to prevent a marketing grant. The DCGI contended that the scheme of the Patents Act and the DCA were completely different and that the two laws operated distinctly and in separate areas. Thus, it was not within the scope of DCA to refuse to grant Cipla a license on the alleged ground of violation of the Patents Act. A High Court Single Judge agreed with the DCGI. The High Court judge found that there was no “patent linkaging” in the legislation which would deny space for generic medicines, and the resultant saving of expenditure and health costs.
Bayer appealed to the High Court of Delhi where it argued that the Patents Act, read in conjunction with the DCA, provided the concept of patent linkage so as to prevent licensing of generic drugs by non-patent holders. Cipla, argued on the contrary that patent linkage did not exist in Indian law. Not only had Parliament consciously avoided patent linkage, but the DCA itself had been amended several times since its initial enactment in 1940, and there had never been an attempt to bring about any linkage between the DCA and the Patents Act. Cipla contended that the scheme and purpose of the two acts were entirely different - while DCA is concerned with the standards to be followed in the manufacturing, sale, importation and distribution of drugs and chemicals in the country, the Patents Act is concerned with the grant of patents for inventions.
The Court affirmed the High Court judgment. The court held that the Patent Act does not confer a right to market the product . Itonly prevents the government from infringing patents; it creates no duty or positive obligation on the central government, or any department thereof, to protect a patent from infringement. The Court found that the mere inclusion of a ‘patent status’ section in an application for marketing approval of a modified/generic version of a drug did not support patent linkage. Requiring DCGI to protect against patent infringements would entail determining the validity of patents, outside the scope of its knowledge and responsibilities. Finally, the Court recognized many developed countries’ disfavor of patent linkage due to interests in improving public health care accessibility and affordability. The Court expounded on the view that patent protection was now often viewed as “the ugly face of globalization, seemingly a hazard to public health and travesty of social justice.” Consequently, Bayer’s appeal was dismissed.
Bayer appealed the decision to the Indian Supreme Court in March 2010. In Dec 2010, the Supreme Court dismissed the appeal. The Court noted that the DCGI had already granted marketing approval to Cipla and that Bayer's infringement suit was pending before the Delhi High Court where the injunction sought by Bayer would be decided.
This was the first case in India where the issue of patent linkage was extensively discussed. The judgment clarified the debate by categorically holding that patent linkages cannot be read into existing Indian law. The case also involved an issue of the larger public interest because the patent linkage system sought by Bayer would have delayed the entry of generic versions of medicines in the market and therefore adversely affected access to medicines.